Stability_SOW_02-05-14.pdf

Statement of Work‐ Stability Extension for Peramivir IV Drug Supplies in USG Vendor‐

Managed Inventory

C.1 Background and Need

Intravenous peramivir is an antiviral drug that is in development for the treatment of influenza.

It is a member of the neuraminidase class of drugs. In 2009, during the H1N1 pandemic, an emergency authorization (EUA) was issued by the FDA for its use in treating severely ill, hospitalized patients infected with influenza. To meet public health needs, HHS purchased several thousand treatment courses of IV peramivir for the strategic national stockpile (SNS) and made them available to physicians of an emergency treatment basis. HHS/BARDA is interested in extending the shelf‐life of this material to 120 months.

C.2 Project Objective

The objective of this solicitation is to extend the stability of this product to 120 months.

Therefore, solicitations for stability testing of the following criteria and schedule are sought.

Three lots of IV peramivir are currently being held in the SNS, lots 7438, 7439 and C307 (for clarity, these “returned sample” lots will be designated 7438CS, 7439CS and C0307CS, as distinct from C307, which is a portion of lot C307 that is being held by a contractor who performed the prior testing).

C.3 Scope of Work

The contractor shall provide all labor, equipment, supplies, and services necessary to perform the project objective. Cost estimates for transport and storage (under GMP conditions) costs of test article are to be included in the proposal. An offeror may perform all the work in‐house or can subcontract portions of the work as needed.

C.4 Technical Requirements

Stability testing for lots 7438CS and 7439CS at T = 72, 84, and 96 months is requested (stability data on these lots has been obtained for the first 60 months). For lot C307CS, testing at T = 60, 72, 84, 96, 108 and 120 months is requested (48 month stability data already obtained).

In addition, two (2) timepoints will be added to Lot C0307, one at 60 months and one at 96 months. Testing will be performed under GLP conditions and include the use of validated assays to test visual appearance, pH, purity using an HPLC Assay (a protocol will be provided), particulates, endotoxin and sterility.

The IV peramivir in the stockpile was filled and finished in 15 ml bottles. Since the bottles are capped with rubber stoppers, extractible/leachable testing is required of the IV peramivir test article using validated assays of one or more of the following analytical techniques: GC/FID, GC/MS, LC/UV or LC/MS. If validation of appropriate assays is necessary, cost and timelines for validation should be included in the proposal. Offeror should provide a rationale for number of repeat tests/samples necessary to obtain accurate results. For testing timepoints and schedule, see Table 1:

Table 1.

25C 60%RH Stability Tests Time Points (Months)

Stability Tests Visual Appearance 60 72 84 96 108 120

Time Points (Months) pH 2 3 3 2 1 1

# of Lots

Number of Lots HPLC Assay & Impurities 2 3 3 2 1 1

Inverted Particulates 2 3 3 2 1 1

Endotoxin 2 3 3 2 1 1

Sterility 2 3 3 2 1 1 extractible 2 1 3 2 1 1 leachable 2 1 3 2 1 1

The next stability timepoint of lots 7438 and 7439 will be January 2015. Lot C307 is currently being held by a vendor and the appropriate number of vials will need to be transferred to the selected vendor for holding and testing. A separate equivalency testing will be performed on this lot at the 60 (October, 2014) and 96 month (October, 2017) time points to determine equivalency between vials stored in the SNS and those at the vendor.

These tests will be conducted until year 10 (2019).

C.5 Reporting Schedule

Written report yearly and test results will be provided to USG as test results become available.

Report need not be more than 1‐2 pages in length.

C.6 Special Considerations

None

C.7 Government Furnished Property

Test article and HPLC protocol will be provided to the vendor upon request.

C.8 References

None

C.9 Deliverables

At the conclusion of 10 year stability/extractible‐leachable testing, a full report will be provided

USG, detailing test results, with figures and tables.